Fluid Line Occlusion Detection System And Methods

ABSTRACT

The systems, methods and articles described herein are directed to at least one pressure sensor along a downstream fluid line which senses fluid pressure and assists an occlusion detection feature in determining the presence of occlusions in the downstream fluid line. In addition, the system can dynamically adapt the occlusion detection feature based on a delivery of fluid, such as a bolus, in order to prevent the system from creating a false alarm regarding an occlusion of the downstream fluid line.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of and claims the benefit of priorityunder 35 U.S.C. § 120 of U.S. patent application Ser. No. 15/045,875filed Feb. 17, 2016, which is a continuation of and claims the benefitof priority under 35 U.S.C. § 120 of U.S. patent application Ser. No.13/928,181 filed Jun. 26, 2013 entitled “Fluid Line Occlusion DetectionSystem And Methods” the disclosure of which is incorporated herein byreference.

BACKGROUND

A hospital patient often has the need for multiple intravenous (IV)infusions from multiple supplies of fluids, such as drugs. This canrequire the use of multiple infusion pumps that are connected to thepatient and to fluid containers via fluid lines. In addition, each fluidinfusion pump can be programmed to pump fluid to the patient at avariety of infusion rates. The infusion rates can depend on a number offactors including type of fluid, such as drugs, and the needs of thepatient.

Infusion pumps can provide an efficient way to deliver a fluid to apatient at a programmed infusion rate, as well as deliver one or moreboluses of fluid. In addition, infusion pumps can include a variety ofsafety features which can monitor and ensure that the proper amount offluid is being delivered to the patient, such as at the programmedinfusion rate. For example, infusion pumps can include one or morefeatures and programs which detect for occlusions in the fluid line.Therefore, when an occlusion forms in the fluid line, such as due to aclot forming in the fluid line, an alarm can be activated which canallow a medical professional to assist in fixing the problem. This canimprove patient care by ensuring the patient is receiving the prescribedor programmed amount of one or more fluids.

Although some infusion pumps include features which detect for theproper delivery of fluid, such as an occlusion detection feature, othercharacteristics of a delivery system can create false alarms. Forexample, changes in fluid infusion rates, such as during the delivery ofa bolus, can cause a spike in fluid pressure which can be interpreted asan occlusion from the occlusion detection feature. These false alarmscan interrupt medical staff from performing jobs, such as for caring forother patients in need. Therefore, false alarms can at least waste timeand reduce the quality of care which medical staff can provide topatients.

SUMMARY

Disclosed is a patient care system for infusing fluid to a patient. Thesystem includes at least one fluid infusion pump which is connected to arespective fluid supply for pumping the contents of a fluid supply to apatient via a fluid supply line. The system can include at least onepressure sensor positioned downstream the fluid infusion pump which cansense pressure along at least the downstream fluid line which extendsbetween the fluid infusion pump and the patient. In addition, the systemcan include a programming module which can dynamically adapt, based on aprogrammed bolus delivery of fluid, in order to prevent the system fromcreating a false alarm regarding an occlusion in the downstream fluidline.

In one aspect, there is disclosed a method for dynamically adapting afluid delivery system, the method comprising: dynamically adapting,based on a programmed bolus of fluid for delivery to a patient, anocclusion detection feature which activates an alarm when detecting atleast a fluid line pressure indicating an occlusion in a fluid line;delivering the programmed bolus of fluid to the patient; and restoringthe occlusion detection feature wherein the fluid line pressureindicating an occlusion in the fluid line is restored at a rate whichprevents falsely activating the alarm.

In another aspect, there is disclosed a patient care system for infusinga medical fluid, the patient care system comprising: a fluid supplyadapted to hold a medical fluid; a fluid line providing fluidcommunication between the fluid supply and a patient; an infusion pumpcontrolling fluid flow along the fluid line between the fluid containerand the patient; a pressure sensor configured to sense pressure in thefluid line between the infusion pump and the patient; and a programmingmodule including an occlusion detection program and one or morealgorithms configured to dynamically adapt, based on a programmed bolusof fluid for delivery to a patient, in order to detect occlusions in thefluid line and prevent activation of a false occlusion alarm.

The details of one or more variations of the subject matter describedherein are set forth in the accompanying drawings and the descriptionbelow. Other features and advantages of the subject matter describedherein will be apparent from the description and drawings, and from theclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects will now be described in detail with referenceto the following drawings.

FIG. 1 is a front view of a patient care system having four fluidinfusion pumps, each of which is connected to a respective fluid supplyfor pumping the contents of the fluid supply to a patient.

FIG. 2 is an enlarged view of a portion of the patient care system ofFIG. 1 showing two of the fluid infusion pumps mounted at either side ofa programming module, and the displays and control keys of each, withthe programming module being capable of programming both infusion pumps.

FIG. 3 is a perspective view of one of the fluid infusion pumps of FIGS.1 and 2 with its front door open.

FIG. 4 is a block diagram showing an occlusion detection program of theprogramming module monitoring the downstream fluid line pressure of thepatient care system.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

Disclosed is a patient care system for infusing fluid to a patient. Thesystem includes at least one fluid infusion pump which is connected to arespective fluid supply for pumping the contents of a fluid supply to apatient via a fluid supply line. The system can include at least onepressure sensor positioned downstream the fluid infusion pump which cansense pressure along at least the downstream fluid line which extendsbetween the fluid infusion pump and the patient. In addition, the systemcan include a programming module which can dynamically adapt, based on aprogrammed bolus delivery of fluid, in order to prevent the system fromcreating a false alarm regarding an occlusion in the downstream fluidline.

Referring now in more detail to the drawings in which like referencenumerals refer to like or corresponding elements among the severalviews, there is shown in FIG. 1 a patient care system 20 having fourinfusion pumps 22, 24, 26, and 28 each of which is fluidly connectedwith an upstream fluid line 30, 32, 34, and 36, respectively. Each ofthe four infusion pumps 22, 24, 26, and 28 is also fluidly connectedwith a downstream fluid line 31, 33, 35, and 37, respectively. The fluidlines can be any type of fluid conduit, such as tubing, through whichfluid can flow through.

Fluid supplies 38, 40, 42, and 44, which may take various forms but inthis case are shown as bottles, are inverted and suspended above theinfusion pumps 22, 24, 26 and 28. Fluid supplies may also take the formof bags or other types of containers. Both the patient care system 20and the fluid supplies 38, 40, 42, and 44 are mounted to a roller standor IV pole 46.

A separate infusion pump 22, 24, 26, and 28 is used to infuse each ofthe fluids of the fluid supplies into the patient. The infusion pumpsare flow control devices that will act on the respective fluid line tomove the fluid from the fluid supply through the fluid line to thepatient 48. Because individual pumps are used, each can be individuallyset to the pumping or operating parameters required for infusing theparticular medical fluid from the respective fluid supply into thepatient at the particular rate prescribed for that fluid by thephysician. Such medical fluids may comprise drugs or nutrients or otherfluids.

Typically, medical fluid administration sets have more parts than areshown in FIG. 1. Many have check valves, drip chambers, valved ports,connectors, and other devices well known to those skilled in the art.These other devices have not been included in the drawings so as topreserve clarity of illustration. In addition, it should be noted thatthe drawing of FIG. 1 is not to scale and that distances have beencompressed for the purpose of clarity. In an actual setting, thedistance between the bottles 38, 40, 42, and 44 and the infusion pumpmodules 22, 24, 26, and 28 could be much greater.

Referring now to FIG. 2, an enlarged view of the front of the infusionpump 24 is shown. The pump includes a front door 50 and a handle 52 thatoperates to lock the door in a closed position for operation and tounlock and open the door for access to the internal pumping and sensingmechanisms and to load administration sets for the pump. When the dooris open, the tube can be connected with the pump. When the door isclosed, the tube can be brought into operating engagement with thepumping mechanism, the upstream and downstream pressure sensors, and theother equipment of the pump. A display 54, such as an LED display, islocated in plain view on the door in this embodiment and may be used tovisually communicate various information relevant to the pump, such asalert indications (e.g., alarm messages). Control keys 56 exist forprogramming and controlling operations of the infusion pump as desired,including programming a bolus delivery of fluid. The infusion pump 22can also include an alarm 120, such as an audio alarm in the form of aspeaker, as shown for example in FIG. 4.

In the embodiment shown, a programming module 60 is attached to the leftside of the infusion pump 22. Other devices or modules, includinganother infusion pump, may be attached to the right side of the infusionpump 22, as shown in FIG. 1. In such a system, each attached pumprepresents a pump channel of the overall patient care system 20. In oneembodiment, the programming module 60 is used to provide an interfacebetween the infusion pump 22 and external devices as well as to providemost of the operator interface for the infusion pump 22.

In addition, the programming module 60 can assist in programming aninfusion rate of the infusion pump 22, including programming a deliveryof one or more boluses of fluid. The programming module 60 can assist inmonitoring any part of the patient care system 20, including the one ormore pressure sensors, in order to ensure the patient care system 20 isproviding effective care to the patient. Furthermore, the programmingmodule 60 can assist in ensuring that the proper amounts of one or morefluids are being delivered to the patient at the programmed infusionrates. Additionally, the programming module can include one or moreprograms which can assist in monitoring one or more fluid lines, such asto detect for occlusions in the fluid lines.

The programming module 60 can include a display 62 for visuallycommunicating various information, such as operating parameters, alertindications, and alarm messages, including warnings or alarms. Theprogramming module 60 may also include a speaker to provide audiblealarms. The programming module can also have various input devices,including control keys 64 and a bar code scanner (not shown) forscanning information relating to the infusion, the patient, the caregiver, or other. The programming module also has a communications system(not shown) with which it may communicate with external equipment suchas a medical facility server or other computer and with a portableprocessor, such as a handheld portable digital assistant (“PDA), or alaptop-type of computer, or other information device that a care givermay have to transfer information as well as to download drug librariesto a programming module or pump. In addition, the programming module 60can communicate with some external equipment which can provide sensedsystem parameters, such as fluid line pressure and changes in infusionrate.

The communications system may take the form of a radio frequency (“RF”)(radio frequency) system, an optical system such as infrared, a BlueTooth system, or other wired or wireless system. The bar code scannerand communications system may alternatively be included integrally withthe infusion pump 22, such as in cases where a programming module is notused, or in addition to one with the programming module. Further,information input devices need not be hard-wired to medical instruments,information may be transferred through a wireless connection as well.

FIG. 2 includes a second pump module 26 connected to the programmingmodule 60. As shown in FIG. 1, more pump modules may be connected.Additionally, other types of modules may be connected to the pumpmodules or to the programming module 60.

Turning now to FIG. 3, an infusion pump 22 is shown in perspective viewwith the front door 50 open, showing the upstream fluid line 30 anddownstream fluid line 31 in operative engagement with the pump 22. Theinfusion pump 22 directly acts on a tube 66 that connects the upstreamfluid line 30 to the downstream fluid line 31 to form a continuous fluidconduit, extending from the respective fluid supply 38 to the patient 48(see FIG. 1), through which fluid is acted upon by the pump to movefluid downstream to the patient. Specifically, a pumping mechanism 70acts as the flow control device of the pump to move fluid though theconduit.

As shown in FIG. 4 the programming module 60 can include an occlusiondetection program 110 which is configured to assist in monitoring atleast the downstream fluid line 31 and detect occlusions. The occlusiondetection program 110 can detect an occlusion, such as in the downstreamfluid line 31, and activate an occlusion warning. The warning can bebroadcast, such as by the alarm 120, in order to allow a medicalprofessional to assist in repairing the occluded fluid line.

In some variations, the occlusion detection program 110 can beprogrammed to act pursuant to one or more algorithms for assisting indetecting occlusions in the fluid line. In addition, the programmingmodule 60 can process the occlusion detection program 110 and the one ormore algorithms, such as with the processor 84, in order to determinewhether there is an occlusion, such as in the downstream fluid line 31.Additionally, the occlusion detection program 110 can input a variety ofinformation about the system, including, for example, fluid pressuresensed by the downstream pressure sensor 82. The processor 84 can thenprocess the pressure readings input into either the occlusion detectionprogram 110 or algorithms in order to assist in determining whetherthere is an occlusion in the downstream fluid line 31.

Any number of alarms can be activated upon the detection of an occlusionwhich can allow a medical professional to assist in relieving the fluidline of the occlusion. An occlusion can disrupt the amount of fluidprogrammed to be delivered to the patient which can thereby impairpatient care and wellbeing. Therefore, the occlusion detection program110 can assist in at least improving patient care.

In some variations, the occlusion detection program 110 can monitor thepressure readings from the downstream pressure sensor 82, however, theocclusion detection program 110 can monitor any number of fluid lines,including an upstream fluid line 30, such as for detecting blood clotformations or a pinched fluid line. For example, when the pressure inthe downstream fluid line 31 changes, such as significantly increases,this can cause the occlusion detection program 110 to detect anocclusion.

The occlusion detection program 110 can provide several benefits for thesystem, including ensuring that the patient receives at least one fluidat a programmed infusion rate. Without such a detection system, thepatient can be harmed by not receiving the diagnosed amount of fluid ata programmed infusion rate.

Although features such as the occlusion detection program 110 canprovide several benefits, false alarms created by at least someocclusion detection features can create a variety of problems. Forexample, a false occlusion detection alarm can result in at least onemedical professional to attend to the alarm which can take away themedical professional's time and attention away from other importantpatient issues.

A variety of system characteristics can cause a false alarm by at leastsome occlusion detection features. For example, when a bolus of fluid isdelivered there can be a significant increase in pressure in the fluidline, such as in the downstream fluid line 31. The downstream pressuresensor 82 can detect the increase in pressure which can be detected bythe occlusion detection feature. In addition, the occlusion detectionfeature can activate an alarm based on this sensed increase in pressure.

In some implementations of the system, at least one of the programmingmodule 60 and occlusion detection program 110 can dynamically adapt to abolus being delivered from the infusion pump 22, including automaticallyupon commencement of the bolus delivery. For example, either theprogramming module 60 or infusion pump 22 can be programmed to deliver abolus of fluid which can automatically prompt the programming module 60,including the occlusion detection program 110, to dynamically adapt suchthat higher pressure readings in the downstream fluid line do not causethe alarm to be activated. This can allow the bolus to create higherfluid pressure in the downstream fluid line without causing falseocclusion alarms.

For example, the programming module 60 and occlusion detection program110 can dynamically adapt by increasing a maximum allowed pressure to besensed in the downstream fluid line 31 before activating the alarm. Oneor more algorithms can be used by either the programming module 60 orocclusion detection program 110 in order to determine appropriatemaximum pressures, including pressure ranges, during the delivery of thebolus.

At least some of the increase in pressure during the delivery of a boluscan be due to resistance in the system, such as resistance in the fluidlines. For example, when a bolus is delivered through the downstreamfluid line 31, the bolus of fluid acts against resistance in thedownstream fluid line 31, such as from the tubing the bolus flowsthrough. In addition, when the bolus acts against the resistance in thesystem, various characteristics can change and it can take some time forthe system to return to a normal state that it was in prior to thedelivery of the bolus. For example, the downstream fluid line 31 canexpand during delivery of the bolus and it may take some time, measuredin seconds to tens of seconds, for the downstream fluid line 31 to relaxafter the delivery of the bolus. During the period in which thedownstream fluid line is relaxing, the infusion rate may return to aprogrammed infusion rate, such as an infusion rate which was programmedfor fluid delivery prior to delivery of the bolus.

In some variations of the system, the programming module can include oneor more algorithms which provide a pressure decay rate of the downstreamfluid line 31 based on the bolus delivered by the system, whentransitioning from a bolus to the primary infusion rate. At least eitherthe programming module or occlusion detection program 110 can use thepressure decay rate to compare to the pressure readings in thedownstream fluid line 31 during relaxation of the system after deliveryof a bolus in order to prevent the activation of false occlusion alarms.For example, this gradual reduction in expected sensed pressurereadings, or pressure decay rate, can consider the time necessary forthe fluid lines, such as the downstream fluid line 31, to recover fromthe delivery of the bolus. Therefore, as the system recovers from thedelivery of the bolus, the system gradually lowers the maximum pressurelimits, including in conformity with the pressure decay rate, in orderto prevent false occlusion alarms, such as from pressure readingsoutside of an expected pressure range given the programmed infusionrate.

The one or more algorithms which assist in providing the maximumpressures and pressure decay rate can consider a variety of variableswhen determining the maximum pressures or pressure decay rates. Forexample, the size and rate of bolus delivery can affect the max pressureand pressure decay rate. The decay rate can include an exponential decayrate. In addition, any number of decay rates can be used for assistingthe programming module, including the occlusion detection program, inpreventing the false detection of occlusions, particularly during thedelivery of a bolus.

An example method of the system includes the programming module 60 beingprogrammed to instruct the infusion pump 22 to deliver a bolus of fluid.The programming module 60 can then automatically and dynamically adaptfluid monitoring features, such as the occlusion detection program 110,in order to prevent false occlusion alarms due to the delivery of thebolus. For example, the bolus information can be input into an algorithmfor determining the approximate maximum pressure which can be detectedin the downstream fluid line 31, as well as a pressure decay rate forafter delivery of the bolus. The programming module 60 and occlusiondetection program 110 can use the maximum pressure and pressure decayrate as new pressure limits to compare pressure readings from thedownstream pressure sensor 82. Therefore, although at least one spike inpressure may occur during the delivery of the bolus, the occlusiondetection program 110 will not activate an alarm unless the pressurereaches beyond the new pressure limits, as defined by the maximumpressure and pressure decay rate, such as due to an actual occlusion inthe downstream fluid line.

The one or more pressure sensors, including the downstream pressuresensor 82 and an upstream pressure sensor 80, can take many forms wellknown to those skilled in the art, including a piezoresistive device.Consequently, no further technical details concerning the mechanicalformation of the sensor are presented herein. In addition, at least thedownstream pressure can provide pressure signals in response to pressuresensed in the downstream fluid line 31 of the fluid conduit 66. Thosepressure signals can be analog in form and can be converted to digitalform by an analog-to-digital converter (“A/D”) integral with the sensoror by an A/D located elsewhere in the data stream.

The processor can be in communication with one or more pumps or pumpingmechanisms 70 and it should be understood that other embodiments mayexist in which multiple pump channels associated with a multi-channelpatient care system may be monitored by the same processor. In such anembodiment, the processor performs the same functions for each pumpchannel of the system. As an example, FIG. 1 shows a four pump system inwhich the four pumps 22, 24, 26, and 28 are connected to a commonprogramming module 60 having an internal processor. The processor of theprogramming module 60 may perform the “infusion rate maintenance” forall four pumps.

System characteristics or other reference values for monitoring fluidflow through the fluid lines, including changes in the fluid line due tothe delivery of boluses and the formation of occlusions, can be storedin a memory which can be included in the programming module and whichthe processor can access. The programs and algorithms of the processor,including the occlusion detection program 110 and algorithms, may bestored in the same memory, or in another memory. Use of memory to storeprograms and data is well known and no further details are providedhere. Values and other programming may also be input into the memoryusing an input device, such as control keys, or may be preprogrammed.

One or more aspects or features of the subject matter described hereinmay be realized in digital electronic circuitry, integrated circuitry,specially designed ASICs (application specific integrated circuits),computer hardware, firmware, software, and/or combinations thereof.These various implementations may include implementation in one or morecomputer programs that are executable and/or interpretable on aprogrammable system including at least one programmable processor, whichmay be special or general purpose, coupled to receive data andinstructions from, and to transmit data and instructions to, a storagesystem, at least one input device (e.g., mouse, touch screen, etc.), andat least one output device.

These computer programs, which can also be referred to as programs,software, software applications, applications, components, or code,include machine instructions for a programmable processor, and can beimplemented in a high-level procedural and/or object-orientedprogramming language, and/or in assembly/machine language. As usedherein, the term “machine-readable medium” refers to any computerprogram product, apparatus and/or device, such as for example magneticdiscs, optical disks, memory, and Programmable Logic Devices (PLDs),used to provide machine instructions and/or data to a programmableprocessor, including a machine-readable medium that receives machineinstructions as a machine-readable signal. The term “machine-readablesignal” refers to any signal used to provide machine instructions and/ordata to a programmable processor. The machine-readable medium can storesuch machine instructions non-transitorily, such as for example as woulda non-transient solid state memory or a magnetic hard drive or anyequivalent storage medium. The machine-readable medium can alternativelyor additionally store such machine instructions in a transient manner,such as for example as would a processor cache or other random accessmemory associated with one or more physical processor cores.

These computer programs, which can also be referred to programs,software, software applications, applications, components, or code,include machine instructions for a programmable processor, and can beimplemented in a high-level procedural language, an object-orientedprogramming language, a functional programming language, a logicalprogramming language, and/or in assembly/machine language. As usedherein, the term “machine-readable medium” refers to any computerprogram product, apparatus and/or device, such as for example magneticdiscs, optical disks, memory, and Programmable Logic Devices (PLDs),used to provide machine instructions and/or data to a programmableprocessor, including a machine-readable medium that receives machineinstructions as a machine-readable signal. The term “machine-readablesignal” refers to any signal used to provide machine instructions and/ordata to a programmable processor. The machine-readable medium can storesuch machine instructions non-transitorily, such as for example as woulda non-transient solid state memory or a magnetic hard drive or anyequivalent storage medium. The machine-readable medium can alternativelyor additionally store such machine instructions in a transient manner,such as for example as would a processor cache or other random accessmemory associated with one or more physical processor cores.

To provide for interaction with a user, the subject matter describedherein can be implemented on a computer having a display device, such asfor example a liquid crystal display (LCD) monitor for displayinginformation to the user and a keyboard and a pointing device, such asfor example a mouse or a trackball, by which the user may provide inputto the computer. Other kinds of devices can be used to provide forinteraction with a user as well. For example, feedback provided to theuser can be any form of sensory feedback, such as for example visualfeedback, auditory feedback, or tactile feedback; and input from theuser may be received in any form, including, but not limited to,acoustic, speech, or tactile input. Other possible input devicesinclude, but are not limited to, touch screens or other touch-sensitivedevices such as single or multi-point resistive or capacitive trackpads,voice recognition hardware and software, optical scanners, opticalpointers, digital image capture devices and associated interpretationsoftware, and the like.

The subject matter described herein can be embodied in systems,apparatus, methods, and/or articles depending on the desiredconfiguration. The implementations set forth in the foregoingdescription do not represent all implementations consistent with thesubject matter described herein. Instead, they are merely some examplesconsistent with aspects related to the described subject matter.Although a few variations have been described in detail above, othermodifications or additions are possible. In particular, further featuresand/or variations can be provided in addition to those set forth herein.For example, the implementations described above can be directed tovarious combinations and subcombinations of the disclosed featuresand/or combinations and subcombinations of several further featuresdisclosed above. In addition, the logic flow(s) when depicted in theaccompanying figures and/or described herein do not necessarily requirethe particular order shown, or sequential order, to achieve desirableresults. Other implementations may be within the scope of the followingclaims.

1.-10. (canceled)
 11. A method for dynamically adapting a medical fluiddelivery system for a patient, the fluid delivery system including afluid supply adapted to hold a medical fluid, a fluid line providingfluid communication between the fluid supply and a patient, an infusionpump controlling fluid flow along the fluid line between the fluidcontainer and the patient, a pressure sensor configured to sensepressure in the fluid line between the infusion pump and the patient,and a programming module including an occlusion detection program, themethod comprising: determining that a delivery of a bolus condition hascommenced; increasing a maximum pressure limit that is compared to asensed pressure of the fluid line between the infusion pump and thepatient; gradually lowering the maximum pressure limit over apredetermined time period after commencement of the delivery of thebolus condition
 12. The method of claim 11, wherein the programmingmodule includes at least one processor and memory.
 13. The method ofclaim 11, wherein a sensed pressure of the fluid line is input into atleast one of the occlusion detection program and algorithm.
 14. Themethod of claim 11, wherein the programming module automaticallydynamically adapts upon commencing the delivery of the bolus.
 15. Themethod of claim 11, determining at least one of a maximum pressure and adecay rate.
 16. The method of claim 15, wherein the decay rate includesan exponential decay rate.
 17. The method of claim 15, wherein theocclusion detection program uses at least one of the maximum pressureand decay rate when monitoring the fluid line pressure at least duringthe delivery of the programmed bolus in order to prevent activation of afalse occlusion alarm.